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4. OP0287-HPR ONE-IN-THREE PATIENTS WITH RHEUMATOID ARTHRITIS REPORT CLINICALLY IMPORTANT WORSENING ON THE RHEUMATOID ARTHRITIS IMPACT OF DISEASE (RAID) BETWEEN CLINIC VISITS: ENGAGEMENT AND PATIENT-REPORTED OUTCOME RESULTS FROM A SMARTPHONE APP FOR PATIENT EDUCATION AND REMOTE MONITORING

Author

Doumen, M., primary, De Meyst, E., additional, Piessens, M., additional, Bertrand, D., additional, Joly, J., additional, Pazmino, S., additional, Devinck, M., additional, Westhovens, R., additional, and Verschueren, P., additional

Published
2024
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6. Flemish network on rare connective tissue diseases (CTD): patient pathways in systemic sclerosis. First steps taken

Author

Piette, Y., primary, Van den Bossche, F., additional, Aerts, J., additional, Aerts, N., additional, Ajeganova, S., additional, Badot, V., additional, Berghen, N., additional, Blockmans, D., additional, Brusselle, G., additional, Caeyers, N., additional, De Decker, M., additional, De Haes, P., additional, De Cock, C., additional, De Keyser, F., additional, De Langhe, E., additional, Delcroix, M., additional, De Nutte, H., additional, De Pauw, M., additional, Depicker, A., additional, De Sutter, A., additional, De Sutter, J., additional, Du Four, T., additional, Frank, C., additional, Goubau, J., additional, Guiot, J., additional, Gutermuth, J., additional, Heeman, L., additional, Houssiau, F., additional, Hennes, I., additional, Lenaerts, J., additional, Lintermans, A., additional, Loeys, B., additional, Luyten, H., additional, Maeyaert, B., additional, Malfait, F., additional, Moeyersoons, A., additional, Mostmans, Y., additional, Nijs, J., additional, Poppe, B., additional, Polfliet, K., additional, Ruttens, D., additional, Sabato, V., additional, Schoeters, E., additional, Slabbynck, H., additional, Stuer, A., additional, Tamirou, F., additional, Thevissen, Kristof, additional, Van Kersschaever, G., additional, Vanneuville, B., additional, Van Offel, J., additional, Vanthuyne, M., additional, Van Wabeke, J., additional, Verbist, C., additional, Vos, I., additional, Westhovens, R., additional, Wuyts, W., additional, Yserbyt, J., additional, and Smith, V., additional

Published
2023
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10. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial)

Author

Emery, P, Durez, P, Dougados, M, Legerton, CW, Becker, J-C, Vratsanos, G, Genant, HK, Peterfy, C, Mitra, P, Overfield, S, Qi, K, and Westhovens, R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Biomedical Imaging, Clinical Research, Arthritis, Autoimmune Disease, Rheumatoid Arthritis, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Inflammatory and immune system, Abatacept, Adult, Antirheumatic Agents, Autoantibodies, Biomarkers, Epidemiologic Methods, Female, Humans, Immunity, Cellular, Immunoconjugates, Immunosuppressive Agents, Male, Peptides, Cyclic, Rheumatoid Factor, Synovitis, T-Lymphocytes, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

BackgroundSeveral agents provide treatment for established rheumatoid arthritis (RA), but a crucial therapeutic goal is to delay/prevent progression of undifferentiated arthritis (UA) or very early RA.ObjectiveTo determine the impact of T-cell costimulation modulation in patients with UA or very early RA.MethodsIn this double-blind, phase II, placebocontrolled, 2-year study, anti-cyclic citrullinated peptide (CCP)2-positive patients with UA (not fulfilling the ACR criteria for RA) and clinical synovitis of two or more joints were randomised to abatacept ( approximately 10 mg/kg) or placebo for 6 months; the study drug was then terminated. The primary end point was development of RA (by ACR criteria) at year 1. Patients were monitored by radiography, MRI, CCP2, rheumatoid factor and 28 joint count Disease Activity Score (DAS28) over 2 years.ResultsAt year 1, 12/26 (46%) abatacept-treated versus 16/24 (67%) placebo-treated patients developed RA (difference (95% CI) -20.5% (-47.4% to 7.8%)). Adjusted mean changes from baseline to year 1 in Genant-modified Sharp radiographic scores for abatacepttreated versus placebo-treated patients, respectively, were 0 versus 1.1 for total score, and 0 versus 0.9 for erosion score. Mean changes from baseline to year 1 in MRI erosion, osteitis and synovitis scores were 0, 0.2 and 0.2, respectively, versus 5.0, 6.7 and 2.3 in the abatacept versus placebo groups. Safety was comparable between groups; serious adverse events occurred in one patient (3.6%) in each group.ConclusionAbatacept delayed progression of UA/very early RA in some patients. An impact on radiographic and MRI inhibition was seen, which was maintained for 6 months after treatment stopped. This suggests that it is possible to alter the progression of RA by modulating T-cell responses at a very early stage of disease. Trial registration number NCT00124449.

Published
2010

11. POS0483 PATIENT-PHYSICIAN DISCORDANCE IN DISEASE ACTIVITY ASSESSMENT IS ASSOCIATED WITH LESS CONSISTENT TREAT-TO-TARGET IMPLEMENTATION, IMPAIRING REMISSION OUTCOMES IN EARLY RA: A POST-HOC MEDIATION ANALYSIS OF THE CARERA TRIAL

Author

Doumen, M., primary, Stouten, V., additional, Pazmino, S., additional, De Meyst, E., additional, Diederik, D. C., additional, Bertrand, D., additional, Joly, J., additional, Westhovens, R., additional, and Verschueren, P., additional

Published
2023
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14. POS0829 SAFETY AND EFFICACY OF FILGOTINIB: AN UPDATE FROM THE DARWIN 3 PHASE 2 LONG-TERM EXTENSION WITH A MAXIMUM OF 8.2 YEARS OF EXPOSURE

Author

Westhovens, R., primary, Alten, R., additional, Dagna, L., additional, Kavanaugh, A., additional, Winthrop, K., additional, Barry, J., additional, Besuyen, R., additional, Corallo, C., additional, De Vries, D., additional, Martin, N., additional, Watson, C., additional, Genovese, M., additional, Spindler, A., additional, Stanislavchuk, M., additional, Greenwald, M., additional, and Emery, P., additional

Published
2023
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17. OP0129 EFFECTIVENESS OF COBRA-SLIM WITH OR WITHOUT EARLY ACCESS TO A TEMPORARY 6-MONTH COURSE OF ETANERCEPT IN EARLY RA: PRIMARY OUTCOME OF THE 2-YEAR, PRAGMATIC, RANDOMISED CARERA2020 TRIAL

Author

Bertrand, D., primary, Joly, J., additional, Neerinckx, B., additional, Durez, P., additional, Lenaerts, J., additional, Joos, R., additional, Thevissen, K., additional, Zwaenepoel, T., additional, Geusens, P., additional, Méric De Bellefon, L., additional, Taelman, V., additional, Van Essche, E., additional, Corluy, L., additional, Malaise, M., additional, Vanden Berghe, M., additional, Devink, M., additional, Ajeganova, S., additional, Anne, D., additional, Boutsen, Y., additional, Margaux, J., additional, Peene, I., additional, Van Offel, J., additional, Doumen, M., additional, Pazmino, S., additional, De Meyst, E., additional, Westhovens, R., additional, and Verschueren, P., additional

Published
2023
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18. POS0308 LONG-TERM CLINICAL PROFILE OF FILGOTINIB (FIL) IN PATIENTS (PTS) WITH RHEUMATOID ARTHRITIS (RA) BY CARDIOVASCULAR (CV) RISK FACTORS: A POST HOC SUBGROUP ANALYSIS

Author

Buch, M. H., primary, Gómez-Puerta, J. A., additional, Burmester, G. R., additional, Combe, B., additional, Rajendran, V., additional, Stiers, P. J., additional, Van Hoek, P., additional, Van Beneden, K., additional, Gottenberg, J. E., additional, Tanaka, Y., additional, Aletaha, D., additional, Westhovens, R., additional, and Caporali, R., additional

Published
2023
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19. Current Definitions of Progressive Pulmonary Fibrosis Might Be Inaccurate: Data From a Cohort of Patients With Rheumatoid Arthritis Associated Interstitial Lung Disease

Author

Vermant, M., primary, Goos, T., additional, Gogaert, S., additional, Carlon, M.S., additional, De Crem, N., additional, De Sadeleer, L., additional, De Langhe, E., additional, Dubbeldam, A., additional, Vanaudenaerde, B., additional, Verbeken, E., additional, Verschakelen, J., additional, Weynand, B., additional, Yserbyt, J., additional, Westhovens, R., additional, Verschueren, P., additional, and Wuyts, W.A., additional

Published
2023
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20. Flemish network on rare connective tissue diseases (CTD): patient pathways in systemic sclerosis. First steps taken

Author

Piette, Y., Van den Bossche, F., Aerts, J., Aerts, N., Ajeganova, S., Badot, V., Berghen, N., Blockmans, D., Brusselle, G., Caeyers, N., De Decker, M., De Haes, P., De Cock, C., De Keyser, F., De Langhe, E., Delcroix, M., De Nutte, H., De Pauw, M., Depicker, A., De Sutter, A., De Sutter, J., Du Four, T., Frank, C., Goubau, J., Guiot, J., Gutermuth, J., Heeman, L., Houssiau, F., Hennes, I., Lenaerts, J., Lintermans, A., Loeys, B., Luyten, H., Maeyaert, B., Malfait, F., Moeyersoons, A., Mostmans, Y., Nijs, J., Poppe, B., Polfliet, K., Ruttens, D., Sabato, V., Schoeters, E., Slabbynck, H., Stuer, A., Tamirou, F., Thevissen, Kristof, Van Kersschaever, G., Vanneuville, B., Van Offel, J., Vanthuyne, M., Van Wabeke, J., Verbist, C., Vos, I., Westhovens, R., Wuyts, W., Yserbyt, J., and Smith, V.

Abstract

ABSTRACTDespite the low prevalence of each rare disease, the total burden is high. Patients with rare diseases encounter numerous barriers, including delayed diagnosis and limited access to high-quality treatments. In order to tackle these challenges, the European Commission launched the European Reference Networks (ERNs), cross-border networks of healthcare providers and patients representatives. In parallel, the aims and structure of these ERNs were translated at the federal and regional levels, resulting in the creation of the Flemish Network of Rare Diseases. In line with the mission of the ERNs and to ensure equal access to care, we describe as first patient pathways for systemic sclerosis (SSc), as a pilot model for other rare connective and musculoskeletal diseases. Consensus was reached on following key messages: 1. Patients with SSc should have multidisciplinary clinical and investigational evaluations in a tertiary reference expert centre at baseline, and subsequently every three to 5 years. Intermediately, a yearly clinical evaluation should be provided in the reference centre, whilst SSc technical evaluations are permissionably executed in a centre that follows SSc-specific clinical practice guidelines. In between, monitoring can take place in secondary care units, under the condition that qualitative examinations and care including interactive multidisciplinary consultations can be provided. 2. Patients with early diffuse cutaneous SSc, (progressive) interstitial lung disease and/or pulmonary arterial hypertension should undergo regular evaluations in specialised tertiary care reference institutions. 3. Monitoring of patients with progressive interstitial lung disease and/or pulmonary (arterial) hypertension will be done in agreement with experts of ERN LUNG.

Published
2024
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21. Efficacité et tolérance du filgotinib (FIL) chez les patients âgés de ≥ 75 ans : une analyse post-hoc en sous-groupes de l’étude d’extension à long terme (ELT) FINCH 4

Author

Combe, B., primary, Aletaha, D., additional, Westhovens, R., additional, Gottenberg, J.E., additional, Buch, M.H., additional, Caporali, R., additional, Gómez-Puerta, J.A., additional, Van Hoek, P., additional, Rajendran, V., additional, Stiers, P.J., additional, Hendrikx, T., additional, Burmester, G.R., additional, and Tanaka, Y., additional

Published
2022
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22. Evolution of diffusion capacity in interstitial lung disease associated with rheumatoid arthritis

Author

Vermant, M, primary, Goos, T, additional, Bode, H, additional, De Sadeleer, L J, additional, Verstraete, K, additional, De Crem, N, additional, De Langhe, E, additional, Dubbeldam, A, additional, Verbeken, E, additional, Verschakelen, J, additional, Weynand, B, additional, Yserbyt, J, additional, Westhovens, R, additional, Verschueren, P, additional, and Wuyts, W A, additional

Published
2022
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28. POS0676 EFFICACY AND SAFETY OF FILGOTINIB IN PATIENTS AGED ≥75 YEARS: A POST HOC SUBGROUP ANALYSIS OF THE FINCH 4 LONG-TERM EXTENSION (LTE) STUDY

Author

Aletaha, D., primary, Westhovens, R., additional, Combe, B., additional, Gottenberg, J. E., additional, Buch, M. H., additional, Caporali, R., additional, Gómez-Puerta, J. A., additional, Van Hoek, P., additional, Rajendran, V., additional, Stiers, P. J., additional, Hendrikx, T., additional, Burmester, G. R., additional, and Tanaka, Y., additional

Published
2022
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35. AB0400 A SYSTEMATIC LITERATURE REVIEW AND META-ANALYSIS INTO THE SUCCESS RATE OF GLUCOCORTICOID DISCONTINUATION AFTER THEIR USE AS INITIAL BRIDGING THERAPY IN RHEUMATOID ARTHRITIS PATIENTS IN OBSERVATIONAL COHORTS AND CLINICAL TRIALS

Author

van Ouwerkerk, L., primary, Palmowski, A., additional, Nevins, I., additional, Buttgereit, F., additional, Verschueren, P., additional, Smolen, J., additional, Landewé, R. B. M., additional, Bijlsma, H., additional, Kerschbaumer, A., additional, Westhovens, R., additional, Huizinga, T., additional, Allaart, C., additional, and Bergstra, S. A., additional

Published
2022
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37. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double‐Blind, Placebo‐Controlled Trials

Author

Clowse, Megan E. B., Wallace, Daniel J., Furie, Richard A., Petri, Michelle A., Pike, Marilyn C., Leszczyński, Piotr, Neuwelt, C. Michael, Hobbs, Kathryn, Keiserman, Mauro, Duca, Liliana, Kalunian, Kenneth C., Galateanu, Catrinel, Bongardt, Sabine, Stach, Christian, Beaudot, Carolyn, Kilgallen, Brian, Gordon, Caroline, Batalov, A., Bojinca, M., Djerassi, R., Duca, L., Horak, P., Kolarov, Z., Milasiene, R., Monova, D., Otsa, K., Pileckyte, M., Popova, T., Radulescu, F., Rashkov, R., Rednic, S., Repin, M., Stoilov, R., Tegzova, D., Vezikova, N., Vitek, P., Zainea, C., East, Far, Baek, H., Chen, Y., Chiu, Y., Cho, C., Chou, C., Choe, J., Huang, C., Kang, Y., Kang, S., Lai, N., Lee, S., Park, W., Shim, S., Suh, C., Yoo, W., Armengol, H. Avila, Zapata, F. Avila, Santiago, M. Barreto, Cavalcanti, F., Chahade, W., Costallat, L., Keiserman, M., Alcala, J. Orozco, Remus, C. Ramos, Roimicher, L., AbuShakra, M., Agarwal, V., AgmonLevin, N., Kadel, J., Levy, Y., Mevorach, D., Paran, D., Reitblat, T., Rosner, I., Shobha, V., Sthoeger, Z., Zisman, D., Ayesu, K., Berney, S., Box, J., Busch, H., Buyon, J., Carter, J., Chi, J., Clowse, M., Collins, R., Dao, K., Diab, I., Dikranian, A., ElShahawy, M., Gaylis, N., Grossman, J., Halpert, E., Huff, J., Jarjour, W., Kao, A., Katz, R., Kennedy, A., Khan, M., Kivitz, A., Kohen, M., LawrenceFord, T., Lawson, J., Levesque, M., Lowenstein, M., Majjhoo, A., Mcarthur, R., McLain, D., Merrill, J., Murillo, A., Neucks, S., Niemer, G., Noaiseh, G., Parker, C., Pantojas, C., Pattanaik, D., Petri, M., Pickrell, P., Reveille, J., RomanMiranda, A., Rothfield, N., Sankoorikal, A., Sayers, M., Singhal, A., Snyder, A., Striebich, C., Vo, Q., von Feldt, J., Wallace, D., Wasko, M., Young, C., Adelstein, S., Hall, S., Littlejohn, G., Nicholls, D., Suranyi, M., Amoura, Z., Bannert, B., Behrens, F., Perez, L.Carreno, Chakravarty, K., Gonzales, F. Diaz, Davies, K., Doria, A., Emery, P., FernándezNebro, A., Govoni, M., Hachulla, E., Hellmich, B., Houssiau, F., Malaise, M., Margaux, J., Maugars, Y., MuñozFernández, S., Navarro, F., OrdiRos, J., Pellerito, R., PenaSagredo, J., Roussou, E., Schmidt, R. E., UcarAngulo, E., Viallard, JF., Westhovens, R., Worm, M., Yee, C. S., Nayiager, S., Reuter, H., Spargo, C., Bazela, B., Brzosko, M., Chudzik, D., Gasztonyi, B., Geher, P., Ionescu, R., Jeka, S., Kemeny, L., Kiss, E., Kotyla, P., Kovacs, L., Kovalenko, V., Kucharz, E., Kwiatkowska, B., Leszczynski, P., Levchenko, E., Lysenko, G., Majdan, M., Mihailov, C., Nalotov, S., Nedelciu, M., Pavel, M., Raskina, T., Rebrov, B., Rezus, E., Semen, T., Smakotina, S., Stanislavchuk, M., Stanislav, M., Szombati, I., Szucs, G., Udrea, G., Zajdel, J., ZonGiebel, A., Bonfiglioli, R., Bustamante, R., Klumb, E., Ramirez, G. Medrano, Neiva, C., Olguin, M., Gonzaga, J.Reyes, Scotton, A., Ayala, S. Sicsik, Ximenes, A., Sharma, R., Srikantiah, C., Aelion, J., Aranow, C., Baker, M., Chadha, A., Chao, J., Chatham, W., Chow, A., Clay, C., CohenGadol, S., Conaway, D., Denburg, J., Escalante, A., Espinoza, L., Fiechtner, J., Fortin, I., Fraser, A., Furie, R., Gladman, D., Goddard, D., Goldberg, M., GonzalezRivera, R., Gorman, J., Griffin, R., Haaland, D., Halter, D., Hemaiden, A., Hobbs, K., Joshi, V., Lim, S., Kalunian, K., Karpouzas, G., Khraishi, M., Lafyatis, R., Lee, S., Lidman, R., Lue, C., Mohan, M., Mease, P., Mehta, C., Mizutani, W., Nami, A., Nascimento, J., Neuwelt, C., Pappas, J., Pope, J., Porges, A., Roane, G., Rosenberg, D., Ross, S., Saadeh, C., Scoville, C., Sherrer, Y., Solomon, M., Surbeck, W., Valenzuela, G., Waller, P., Alten, R., Baerwald, C., Bienvenu, B., Bombardieri, S., Braun, J., Dival, L., Espinosa, G., Fernandez, I. Figueroa, GomezReino, J., Gordon, C., Hiepe, F., Hopkinson, N., Isenberg, D., Jacobi, A., Jorgensen, C., Guern, V. Le, Paul, C., PegoReigosa, J. M., Heredia, J. Rodriguez, RubbertRoth, A., Sabbadini, M., Schroeder, J., Schwarting, A., Spieler, W., Valesini, G., Wollenhaupt, J., Mendoza, A. Zea, and Zouboulis, C.

Published
2017
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41. ECM et TEV dans le développement clinique du filgotinib dans la polyarthrite rhumatoïde : analyse intégrée des essais cliniques de phases 2 et 3

Author

Charles-schoeman, C., primary, Bae, S.C., additional, Chopra, A., additional, Cohen, S.B., additional, Curtis, J., additional, Edward, K., additional, Yamaoka, K., additional, Nash, P., additional, Simon, J.A., additional, Stohl, W., additional, Weinblatt, M., additional, Westhovens, R., additional, Siegel, J., additional, Tiamiyu, I., additional, Ye, L., additional, Jiang, D., additional, Matzkies, F., additional, Jahreis, A., additional, John, S.S., additional, Giles, J.T., additional, and Gottenberg, J.E., additional

Published
2021
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47. Tapering of Etanercept is feasible in patients with Rheumatoid Arthritis in sustained remission: a pragmatic randomized controlled trial.

Author

Bertrand, D, Stouten, V, De Cock, D, Pazmino, S, Doumen, M, de Wergifosse, I, Joly, J, Badot, V, Corluy, L, Hoffman, I, Taelman, V, De Knop, K, Geens, E, Langenaken, C, Lenaerts, JL, Lenaerts, J, Walschot, M, Mannaerts, J, Westhovens, R, and Verschueren, P

Abstract

In patients with rheumatoid arthritis (RA) in sustained remission, tapering of biological disease-modifying anti-rheumatic drugs can be considered. Tapering has already been investigated, but its feasibility remains to be determined. Therefore, we explored the feasibility of tapering etanercept in RA in a setting close to practice. Patients with RA in 28-joint Disease Activity Score (DAS28) remission (≥ 6 months) and treated with etanercept 50 mg weekly (≥ 1 year) were included in the pragmatic 1 year open-label multicentre randomized controlled TapERA (Tapering Etanercept in Rheumatoid Arthritis) trial. Patients were assigned to continue etanercept weekly or to taper to every other week (EOW). Patients who lost remission [DAS28–C-reactive protein (CRP) ≥ 2.6] were re-escalated to etanercept weekly. The primary outcome was the proportion of patients maintaining DAS28-CRP remission for 6 months. Sixty-six patients were randomized to etanercept weekly (n = 34) or EOW (n = 32). After 6 months, 26/34 patients (76%) in the weekly and 19/32 (59%) in the EOW group maintained disease control (p = 0.136). In the EOW group, 20/32 patients (63%) remained on their tapered treatment during the trial. Two patients reintroduced weekly etanercept themselves. Ten patients were re-escalated to etanercept weekly by the rheumatologist, after a median (interquartile range) interval of 3.0 (2.0–6.0) months. Among these patients, 7/10 regained remission after re-escalation, four of them at the next study visit. Although non-inferiority could not be demonstrated, tapering of etanercept to EOW appeared feasible in patients in sustained remission. [ABSTRACT FROM AUTHOR]

Published
2022
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49. Tapering of Etanercept is feasible in patients with Rheumatoid Arthritis in sustained remission: a pragmatic randomized controlled trial

Author

Bertrand, D, primary, Stouten, V, additional, De Cock, D, additional, Pazmino, S, additional, Doumen, M, additional, de Wergifosse, I, additional, Joly, J, additional, Badot, V, additional, Corluy, L, additional, Hoffman, I, additional, Taelman, V, additional, De Knop, K, additional, Geens, E, additional, Langenaken, C, additional, Lenaerts, JL, additional, Lenaerts, J, additional, Walschot, M, additional, Mannaerts, J, additional, Westhovens, R, additional, and Verschueren, P, additional

Published
2021
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50. Effectiveness of different combinations of DMARDs and glucocorticoid bridging in early rheumatoid arthritis: two-year results of CareRA

Author

Stouten, Veerle, Westhovens, Rene, Pazmino, Sofia, De Cock, Diederik, Van der Elst, Kristien, Joly, Johan, Verschueren, Patrick, Maeyaert, B, De Brabanter, G, Devinck, M, Langenaken, C, Lenaerts, J, Corluy, L, Remans, J, Vander Cruyssen, B, Ravelingien, I, Van Essche, E, Vandevyvere, K, Durnez, A, Verbruggen, A, Geens, E, Raeman, F, Joos, R, de Vlam, K, Taelman, V, Vanhoof, J, Coppens, M, Geusens, P, Sileghem, A, Volders, P, Van Den Bosch, F, Verschueren, P, Westhovens, R, and Public Health Sciences

Subjects
Male, Time Factors, early rheumatoid arthritis, Severity of Illness Index, OPPORTUNITY, WINDOW, law.invention, Arthritis, Rheumatoid, Prednisone/administration & dosage, Antirheumatic Agents/administration & dosage, Joints/diagnostic imaging, Randomized controlled trial, law, Prednisone, Pharmacology (medical), Prospective Studies, Leflunomide, treatment, glucocorticoids, TREATMENT STRATEGIES, Middle Aged, Prognosis, OPEN-LABEL, Treatment Outcome, TARGET, Antirheumatic Agents, Rheumatoid arthritis, Arthritis, Rheumatoid/diagnosis, Prednisolone, Drug Therapy, Combination, Female, TRIAL, DMARDs (synthetic), Life Sciences & Biomedicine, Immunosuppressive Agents, medicine.drug, medicine.medical_specialty, REMISSION INDUCTION, effectiveness, Leflunomide/administration & dosage, PREDNISOLONE, Drug Administration Schedule, methotrexate, Sulfasalazine/administration & dosage, Rheumatology, Sulfasalazine, Internal medicine, medicine, Humans, Adverse effect, Immunosuppressive Agents/administration & dosage, Glucocorticoids, Science & Technology, Dose-Response Relationship, Drug, business.industry, Glucocorticoids/administration & dosage, medicine.disease, Radiography, Regimen, Joints, business, Follow-Up Studies
Abstract

ObjectivesTo investigate whether MTX should be combined with an additional DMARD and bridging glucocorticoids as initial treatment for patients with early RA to induce an effective long-term response.MethodsThe Care in early RA study is a two-year investigator-initiated pragmatic multicentre randomized trial. Early RA patients, naïve to DMARDs and glucocorticoids, were stratified based on prognostic factors. High-risk patients were randomized to COBRA-Classic (n = 98): MTX, sulfasalazine, prednisone step-down from 60 mg; COBRA-Slim (n = 98): MTX, prednisone step-down from 30 mg; or COBRA-Avant-Garde (n = 93): MTX, leflunomide, prednisone step-down from 30 mg. Low-risk patients were randomized to COBRA-Slim (n = 43); or Tight Step Up (TSU) (n = 47): MTX without prednisone. Clinical/radiological outcomes at year 2, sustainability of response, safety and treatment adaptations were assessed.ResultsIn the high-risk group 71/98 (72%) patients achieved a DAS28-CRP < 2.6 with COBRA-Slim compared with 64/98 (65%) with COBRA-Classic and 69/93 (74%) with COBRA-Avant-Garde (P = 1.00). Other clinical/radiological outcomes and sustainability of response were similar. COBRA-Slim treatment resulted in less therapy-related adverse events compared with COBRA-Classic (P = 0.02) or COBRA-Avant-Garde (P = 0.005). In the low-risk group, 29/43 (67%) patients on COBRA-Slim and 34/47 (72%) on TSU achieved a DAS28-CRP < 2.6 (P = 1.00). On COBRA-Slim, low-risk patients had lower longitudinal DAS28-CRP scores over 2 years, a lower need for glucocorticoid injections and a comparable safety profile compared with TSU.ConclusionAll regimens combining DMARDs with glucocorticoids were effective for patients with early RA up to 2 years. The COBRA-Slim regimen, MTX monotherapy with glucocorticoid bridging, provided the best balance between efficacy and safety, irrespective of patients’ prognosis.Trial registrationClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01172639.

Published
2019

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